EUCTR2011-000177-31-BG进行中（未招募）不适用
CANVAS: A Randomized Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in [A] Patients with Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-Line Chemotherapy and [B] Patients with EOC in Second Remission - CANVAS
Prima BioMed Ltd0 个研究点目标入组 286 人开始时间: 2012年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 286
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Part A Screening Inclusion Criteria
- •Patients may be enrolled in and randomized to the study only if they meet all of the following criteria at screening:
- •1. Females = 18 years of age at screening with a confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer
- •2. Have undergone or will undergo optimal debulking surgery, defined as = 1 cm of residual tumor
- •3. Eligible for, and plan to undergo standard platinum and taxane first-line chemotherapy
- •4. Signed an informed consent form (ICF)
- •5. Willing and able to complete study procedures within the study timelines
- •6. Mucin 1-positive tumor as determined by central immunohistopathology
- •7. Adequate renal function in the opinion of the investigator based on serum creatinine and/or glomerular filtration rate
- •8. Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) = 2 × upper limit of normal (ULN) and serum bilirubin = 1.5 × ULN unless Gilbert’s syndrome has previously been confirmed for the patient.
- •9. Adequate bone marrow function: white blood cells (WBCs) = 3.0 K/µL, absolute neutrophil count (ANC) = 1.5 × 109/L, hemoglobin = 9 g/dL, and platelets = 100 × 109/L
- •10. Life expectancy of at least 12 months at the time of screening as judged by the investigator
- •11. Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of study agent. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner as specified above.
- •Part A Baseline Inclusion and Exclusion Criteria
- •Patients must meet the following baseline criteria in order to continue to dosing and follow up stages of the study:
- •1. Have achieved complete remission as evidenced by the baseline radiological scan = 32 weeks after randomization; complete remission is defined as no detectable lesion, no relevant abnormalities on physical examination, and a normal CA 125 level
- •2. Have completed at least 3 cycles of platinum- and taxane-based first-line chemotherapy, with or without concurrent bevacizumab
- •3. Have not withdrawn consent from study participation
- •4. Remain willing and able to complete study procedures within the study timelines
- •5. Adequate bone marrow function: WBCs = 3.0 K/µL, ANC = 1.5 × 109/L, hemoglobin = 9 g/dL, and platelets = 100 × 109/L
- •6. Adequate renal function in the opinion of the investigator based on serum creatinine and/or glomerular filtration rate
- •7. Adequate liver function: SGOT/AST and SGPT/ALT = 2 × ULN and serum bilirubin = 1.5 × ULN
- •8. Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of study agent. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner as specified above.
- •9. Have not developed another typ
排除标准
- •Part A Screening Exclusion Criteria
- •Patients are to be excluded from the study at the time of screening for any of the following reasons:
- •1. Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Müllerian tumors, or mucinous carcinoma of the peritoneum
- •2. Malignancy other than EOC, except those that have been in CR for a minimum of 3 years, and except carcinoma in-situ of the cervix or basal cell and squamous cell carcinomas of the skin that have been adequately treated
- •3. Treatment with any investigational product (for any condition) within 4 weeks of screening
- •4. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
- •5. Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication
- •6. Clinically significant abnormalities as measured by ECG
- •7. Active uncontrolled infection
- •8. Uncontrolled hypertension
- •9. Diagnosed immunodeficiency or autoimmune disorder
- •10. Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection
- •11. Pregnant or lactating
- •12. Evidence or history of central nervous system metastasis
- •13. Known hypersensitivity to any of the components of the study agent
- •14. Active or latent infection with Mycobacterium tuberculosis in any body tissue (especially renal and/or lung)
- •15. Any other health condition that would preclude participation in the study in the judgment of the principal investigator.
- •Part B Exclusion Criteria
- •Patients are to be excluded from the study at the time of screening and the baseline visit (defined as the visit within 2 weeks of the first dose) for any of the following reasons:
- •1. More than 2 previous lines of chemotherapy for EOC, fallopian tube, or peritoneal cancer
- •2. Primary platinum-refractory or platinum-resistant disease (i.e., patients who progress prior to cessation of induction therapy [platinum refractory] or recur within 6 months after cessation [platinum resistant])
- •3. Treatment with any investigational product (for any condition) within 4 weeks of screening. Enrolled in or has not completed at least 28 days (prior to screening) since ending another investigational device or drug treatment, or currently receiving other investigational treatments
- •4. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
- •5. Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication
- •6. Diagnosed immunodeficiency or autoimmune disorder
- •7. Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection
- •8. Pregnant or lactating
- •9. Evidence or history of central nervous system metastasis
- •10. Known hypersensitivity to any of the components of the study agent
- •11. Any unresolved persistent toxicities from prior systemic therapy that are either Grade 3 or Grade 4 (except alopecia) per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- •12. Intent to treat patient with both an anti-angiogen
研究者
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